Local Anesthesia With Needle-free Injection System

NCT ID: NCT04028271

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-15

Brief Summary

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The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).

Detailed Description

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Conditions

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Pediatric Anesthesia Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental

local anesthesia applyed with Comfort in system

Group Type EXPERIMENTAL

Comfort-in injection system

Intervention Type DEVICE

local anesthesia during dental treatment

conventional injection

local anesthesia applyed with conventional syringe

Group Type ACTIVE_COMPARATOR

conventional injection with dental needle

Intervention Type OTHER

for local anesthesia during dental treatment

Interventions

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Comfort-in injection system

local anesthesia during dental treatment

Intervention Type DEVICE

conventional injection with dental needle

for local anesthesia during dental treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* In need of treatment of right and left molar teeth of mandible,

* Does not have any systemic disorder,
* High level of communication that can provide logical answers to the questions we ask
* With parental consent,
* Volunteers who want to participate in the research
* 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria

* No need for treatment of right and left molar teeth of mandible,
* Has a systemic condition
* Low level of communication that cannot provide reasonable answers to the questions we ask
* Without parental consent
* Do not want to participate voluntarily in the research
* Do not attend a check-in
* Patients not in the 6-12 age group
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinem yildirim

OTHER

Sponsor Role lead

Responsible Party

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Sinem yildirim

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Okan University Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Marmara universty

Identifier Type: OTHER

Identifier Source: secondary_id

2018/201

Identifier Type: -

Identifier Source: org_study_id

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